MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2023

Event Type  Injury  

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number 2429304-2023-00216.The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that error e311 -white balance incomplete occurred on an unknown endoscope.The event occurred during the beginning of an endobronchial ultrasound bronchoscopy procedure after the patient was sedated for approximately 45 minutes and an error occurred on clv-190 and another scope was tried but the same error occurred.The power unit was turned off and on and error code e931 appeared.Two different lamps were replaced but the same issue recurred.This equipment troubleshooting led to procedural delay.The physician then canceled the procedure due to the error codes produced.Additional follow-up is being performed to determine if medical intervention was required and patient outcome due to cancelled procedure, but the information is unavailable that the time of the report.Related patient identifier # (b)(6); bronchoscope flexible/rigid, model name and serial # -unknown.Related patient identifier # (b)(6); bronchoscope (flexible/rigid), model name and serial # unknown.Related patient identifier # (b)(6); evis exera iii xenon light source, clv -190, serial # unknown.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the procedure was interrupted due to the device malfunction.However, the device was not returned and the root cause of the phenomenon could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17281583
• MDR Text Key: 318642504
• Report Number: 3002808148-2023-06844
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BRONCHOSCOPE -SN/MODEL UNK; BRONCHOSCOPE -SN/MODEL UNK; XENON LIGHT SOURCE, CLV -190 - SN UNK
• Patient Outcome(s): Other